Glossary
What is ICH M7?
The ICH guideline on the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. It uses computational toxicology assessment, a classification into five classes, and the threshold of toxicological concern, commonly 1.5 µg per day for lifetime exposure, with higher acceptable intakes for shorter treatment durations. Certain highly potent groups, including N-nitrosamines, are treated separately.